We studied the clinical efficacy and tolerability, neuropsychological effects, and cost-effectiveness (direct medical costs, direct nonmedical costs, and indirect costs) of vagus nerve stimulation (VNS) in children with Lennox-like syndrome (n = 16). The situation 6 months before implantation of the device is compared with that 6 months after surgery. Seizure frequency and severity are significantly reduced during VNS: 25% of the patients show a reduction in seizure frequency of 50% or greater; overall seizure reduction is 26.9%. Measures of neuropsychological outcome show a moderate improvement in mental functioning, behavior, and mood. The scores for mood and mental age improve independently of seizure control. Side effects are minor and transient. There is a significant reduction in direct non-health care costs, ergotherapy, and the number of days of sub-optimal functioning of the child. The costs during the 6 postoperative months are 2,876.06 Euros less than the costs during the 6 months before VNS; the payback period is 2.3 years.

(1) There was a significant reduction in seizure frequency and severity. (2) No serious side effects were recorded. (3) No negative effects on cognition or quality of life were apparent. (4) Patients with highest baseline mental functioning showed the highest seizure reduction. (5) Those patients with less disturbed EEG (high background activity and less interictal epileptic activity) showed the highest seizure reduction.

Objective: The vagus nerve has important immunological functions that may be relevant for its anticonvulsive action. We postulate that this anticonvulsive action is activated by a shift in the immune system resulting in a reduction of neurotoxic and an increase of neuroprotective tryptophan metabolites. Methods: Eleven patients with refractory epilepsy and 11 controls matched for age and gender were included in this study. The primary outcome measure was a 50% seizure reduction. Other variables were pro-inflammatory cytokines IL-6 and TNF-α, anti-inflammatory cytokine IL-10, cortisol, and the tryptophan metabolites 3-hydroxykynurenine (3-OH-KYN), kynurenic acid (KYNA), kynurenine, serotonin (5-HT) and 5-hydroxyindol acetic acid (5-HIAA). Blood samples were scheduled during baseline, and in week 28 of add-on treatment. Results: IL-6 levels were higher in the responders than in the control group, and decreased after vagus nerve stimulation (VNS), whereas IL-10 was low and increased after VNS. In nonresponders, VNS resulted in an increase of IL-6 plasma levels and in a decrease of IL-10. Cortisol concentrations are higher in the epilepsy group than in the control group. After VNS, these concentrations decreased. The concentrations of the tryptophan metabolites were lower in the epilepsy group than in the control group. The KYNA ratios are defined as the ratio of neuroprotective KYNA versus neurotoxic 3-OH-KYN and KYNA versus neurotoxic kynurenine: these ratios were lower in epilepsy patients than in controls, and they both moderately increased after VNS. Conclusion: The outcome of this preliminary study indicates that VNS causes a rebalancing of the immune system. This results in: (1) a reduction of neurotoxic and an increase of neuroprotective kynurenine metabolites and (2) in the normalization of cortisol levels.

No abstract

Behavioral approaches to treating patients following lumbar disc surgery are becoming increasingly popular. The treatment method is based on the assumption that pain and pain disability are not only influenced by somatic pathology, if found, but also by psychological and social factors. A recent study highlighted the effectiveness of cognitive-behavioral interventions, as compared to no treatment, for chronic low back patients. However, to the authors' knowledge, there is no randomized controlled trial that evaluates a behavioral program for patients following lumbar disc surgery. The purpose of this study was to assess the effectiveness of a behavioral graded activity (BGA) program compared to usual care (UC) in physiotherapy following first-time lumbar disc surgery. The BGA program was a patient-tailored intervention based upon operant therapy. The essence of the BGA is to teach patients that it is safe to increase activity levels. The study was designed as a randomized controlled trial. Assessments were carried out before and after treatment by an observer blinded to treatment allocation. Patients suffering residual symptoms restricting their activities of daily living and/or work at the 6 weeks post-surgery consultation by the neurosurgeon were included. The exclusion criteria were: complications during surgery, any relevant underlying pathology, and any contraindication to physiotherapy or the BGA program. Primary outcome measures were the patient's Global Perceived Effect and the functional status. Secondary measures were: fear of movement, viewing pain as extremely threatening, pain, severity of the main complaint, range of motion, and relapses. Physiotherapists in the BGA group received proper training. Between November 1997 and December 1999, 105 patients were randomized; 53 into the UC group and 52 into the BGA group. The unadjusted analysis shows a 19.3% (95% CI: 0.1 to 38.5) statistically significant difference to the advantage of the UC group on Global Perceived Effect. This result, however, is not robust, as the adjusted analyses reveal a difference of 15.7% (95% CI: -3.9 to 35.2), which is not statistically significant. For all other outcome measures there were no statistically significant or clinically relevant differences between the two intervention groups. In general, the physiotherapists' compliance with the BGA program was satisfactory, although not all treatments, either in the BGA or the UC group, were delivered exactly as planned, resulting in less contrast between the two interventions than had been planned for. There was one re-operation in each group. The BGA program was not more effective than UC in patients following first-time lumbar disc surgery. For Global Perceived Effect there was a borderline statistically significant difference to the advantage of the UC group. On functional status and all other outcome measures there were no relevant differences between interventions. The number of re-operations was negligible, indicating that it is safe to exercise after first-time disc surgery.